3m Fluoropolymer Contact Lens (flurofocon A)
FDA PMAU (US FDA PMA)
by 3m Company
Identity
- Trade Name
- 3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A) FDA PMA
- Generic Name
- Lens, contact (polymethylmethacrylate) FDA PMA
Identifiers
- PMA Number
- P870009 FDA PMA
- FDA Product Code
- HPX FDA PMA
Classification
- Device Class
- U FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 (Panel Track) FDA PMA
The Fluoropolymer Contact Lens (Flurofocon A) is a contact lens designed for ophthalmic use, classified as a polymethylmethacrylate lens. It is intended for correction or modification of vision by direct application to the cornea, adhering to the eye’s surface to provide clear, uninterrupted vision.
This device is supplied as a single-use item and is regulated under an FDA Premarket Approval (PMA) with the approval number P870009. It is manufactured by 3M Company and falls under the product code HPX, with a supplement filed for changes in design, components, specifications, or materials. The lens is intended for use in clinical settings by trained professionals.
Frequently asked questions
What is the primary purpose of the 3M Fluoropolymer Contact Lens (Flurofocon A) and how does it differ from standard contact lenses?
The 3M Fluoropolymer Contact Lens (Flurofocon A) is specifically designed as a polymethylmethacrylate (PMMA) contact lens for ophthalmic use, intended to correct or modify vision by resting directly on the cornea. Unlike some modern soft contact lenses, this lens is a rigid gas-permeable (RGP) type, offering a durable, clear surface for uninterrupted vision. Its rigid construction provides stability and sharp vision, making it suitable for clinical settings where precision is critical.
Is the 3M Fluoropolymer Contact Lens (Flurofocon A) intended for single-use or reusable applications, and what does this mean for clinical workflow?
The lens is explicitly supplied as a single-use item, meaning each lens is intended for one patient application only. This design reduces the risk of cross-contamination and eliminates the need for sterilization or cleaning between uses, simplifying clinical workflows and ensuring patient safety. Clinicians should discard the lens after removal from the patient’s eye.
What regulatory pathway does the 3M Fluoropolymer Contact Lens (Flurofocon A) follow, and what does this imply for its use in clinical practice?
The lens is regulated under the FDA Premarket Approval (PMA) pathway, with approval number P870009, indicating it underwent rigorous review for safety and effectiveness before market authorization. This classification (U, or Unclassified) reflects its specialized ophthalmic purpose. Clinicians should confirm compliance with the approved labeling and use it only as intended for vision correction in controlled settings by trained professionals.
Are there different sizes or models available for the 3M Fluoropolymer Contact Lens (Flurofocon A), and how might this affect patient fitting?
The provided data does not specify distinct sizes or models for the Flurofocon A lens, but as a PMMA contact lens, it would typically be available in various base curves and diameters to accommodate different corneal shapes and prescriptions. Clinicians should rely on standard fitting protocols and manufacturer guidelines to select the appropriate lens parameters for each patient’s unique ocular anatomy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P870009 | U | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA PMA P870009 24 fields · synced Sep 18, 2026